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| clinical research management ms: Fundamentals of Clinical Trials Lawrence M. Friedman, Curt Furberg, David L. DeMets, 1998 This classic reference, now updated with the newest applications and results, addresses the fundamentals of such trials based on sound scientific methodology, statistical principles, and years of accumulated experience by the three authors. |
| clinical research management ms: Autoimmune Neurology , 2016-03-11 Autoimmune Neurology presents the latest information on autoimmune neurologic disease, the immune response to the body where organs run wild, causing the immune system to attack itself. Autoimmunity is a main element in numerous nervous system diseases and can target any structure within the central or peripheral nervous system. Over the past 20 years, significant advances in our understanding of the pathophysiology of autoimmune disorders, including the use of biomarkers has led to new diagnosis and treatment options. Neurologic conditions associated with autoimmune reactions include dementia, neuromuscular disease, epilepsy, sleep disorders, diabetes, and other common neurologic disorders and disease. This current tutorial-reference will be a must-have title for clinical neurologists, research neurologists, neuroscientists, and any medical professional working with autoimmune disease and disorders. - Includes comprehensive coverage of autoimmune neurology - Details the latest techniques for the study, diagnosis, and treatment of diseases and disorders, including dementia, neuromuscular disease, epilepsy, and sleep disorders - Presents a focused reference for clinical practitioners and the clinical neurology and neurology research communities |
| clinical research management ms: Sharing Clinical Trial Data Institute of Medicine, Board on Health Sciences Policy, Committee on Strategies for Responsible Sharing of Clinical Trial Data, 2015-04-20 Data sharing can accelerate new discoveries by avoiding duplicative trials, stimulating new ideas for research, and enabling the maximal scientific knowledge and benefits to be gained from the efforts of clinical trial participants and investigators. At the same time, sharing clinical trial data presents risks, burdens, and challenges. These include the need to protect the privacy and honor the consent of clinical trial participants; safeguard the legitimate economic interests of sponsors; and guard against invalid secondary analyses, which could undermine trust in clinical trials or otherwise harm public health. Sharing Clinical Trial Data presents activities and strategies for the responsible sharing of clinical trial data. With the goal of increasing scientific knowledge to lead to better therapies for patients, this book identifies guiding principles and makes recommendations to maximize the benefits and minimize risks. This report offers guidance on the types of clinical trial data available at different points in the process, the points in the process at which each type of data should be shared, methods for sharing data, what groups should have access to data, and future knowledge and infrastructure needs. Responsible sharing of clinical trial data will allow other investigators to replicate published findings and carry out additional analyses, strengthen the evidence base for regulatory and clinical decisions, and increase the scientific knowledge gained from investments by the funders of clinical trials. The recommendations of Sharing Clinical Trial Data will be useful both now and well into the future as improved sharing of data leads to a stronger evidence base for treatment. This book will be of interest to stakeholders across the spectrum of research-from funders, to researchers, to journals, to physicians, and ultimately, to patients. |
| clinical research management ms: Burst the Bubble Tia Warrick, 2024-02-21 Burst the Bubble is a comprehensive guide by Tia Warrick designed to demystify the clinical research industry and serve as an inspiring resource for individuals aspiring to enter this competitive field. The book explores various facets of clinical research, shedding light on different functions, key stakeholders, and the often-overlooked intricacies of the profession. The book aims to clarify the multifaceted nature of clinical research careers through engaging discussions, offering insights that can help readers make informed decisions about their professional paths. To make the reading experience interactive, the book incorporates question processes that guide readers in discovering the most suitable career within the clinical research landscape. Additionally, it offers a glimpse into the daily routines of specific roles, providing a firsthand account of the challenges and rewards inherent in each position. The recurring theme of Benefit or Bust underscores the importance of understanding the industry's nuances and making strategic choices for a successful and fulfilling career. Furthermore, the book goes beyond entry-level insights, catering to individuals who have experience in the field but may have only seen it from a limited perspective. With a commitment to sharing insider knowledge and trade secrets, Burst the Bubble aims to empower readers with the information needed to navigate the complexities of the clinical research industry and thrive in their chosen careers. Whether you're a newcomer eager to break into the field or a seasoned professional seeking a more comprehensive understanding, this book is your guide to unlocking the full potential of a career in clinical research. |
| clinical research management ms: Biostatistics in Clinical Trials Carol K. Redmond, Theodore Colton, 2001-04-25 The second volume in the Wiley reference series in Biostatistics. Featuring articles from the prestigious Encyclopedia of Biostatistics, many of which have been fully revised and updated to include recent developments, Biostatistics in Clinical Trials also includes up to 25% newly commissioned material reflecting the latest thinking in: Bayesian methods Benefit/risk assessment Cost-effectiveness Ethics Fraud With exceptional contributions from leading experts in academia, government and industry, Biostatistics in Clinical Trials has been designed to complement existing texts by providing extensive, up-to-date coverage and introducing the reader to the research literature. Offering comprehensive coverage of all aspects of clinical trials Biostatistics in Clinical Trials: Includes concise definitions and introductions to numerous concepts found in current literature Discusses the software and textbooks available Uses extensive cross-references helping to facilitate further research and enabling the reader to locate definitions and related concepts Biostatistics in Clinical Trials offers both academics and practitioners from various disciplines and settings, such as universities, the pharmaceutical industry and clinical research organisations, up-to-date information as well as references to assist professionals involved in the design and conduct of clinical trials. |
| clinical research management ms: Clinical Research Informatics Rachel Richesson, James Andrews, 2012-02-15 The purpose of the book is to provide an overview of clinical research (types), activities, and areas where informatics and IT could fit into various activities and business practices. This book will introduce and apply informatics concepts only as they have particular relevance to clinical research settings. |
| clinical research management ms: Peterson's Graduate & Professional Programs: An Overview--Profiles of Institutions Offering Graduate & Professional Work Peterson's, 2011-06-01 Graduate & Professional Programs: An Overview--Profiles of Institutions Offering Graduate & Professional Work contains more than 2,300 university/college profiles that offer valuable information on graduate and professional degree programs and certificates, enrollment figures, tuition, financial support, housing, faculty, research affiliations, library facilities, and contact information. |
| clinical research management ms: Clinical Trials and Human Research Fay A. Rozovsky, Rodney K. Adams, 2003-06-10 This easy-to-read reference book provides a practical approach for dealing with the legal and regulatory compliance issues involved in human research. Covering a broad range of topics, such as consent, confidentiality, subject recruitment and selection, the role of the investigator and Institutional Review Board, it offers timely and useful strategies for achieving regulatory compliance while reducing liability. In addition, insurance, quality management, accreditation, and risk management are topics examined in the book. The practical insights found in this volume are not found in other books on the subject. Clinical Trials and Human Research is a practical tool to help anyone involved in clinical research. |
| clinical research management ms: Clinical Research Law and Compliance Handbook John E. Steiner, 2006 Law/Ethics |
| clinical research management ms: Clinical Exercise Science Andrew Scott, Christopher Gidlow, 2016-01-22 Clinical Exercise Science is an introduction to core principles and best practice in exercise science for students and practitioners working with clinical populations. Combining the latest scientific research with evidence-based, practitioner-led analysis, the book offers integrated coverage of the full clinical exercise curriculum, including: Pathophysiology of exercise and disease Exercise as a clinical intervention Exercise, nutrition, and lifestyle Health behaviour change Clinical skills in exercise science The book covers a wide range of conditions, including cardiovascular disease, pulmonary disease, metabolic disease and mental health problems, and includes an array of useful features to guide student learning, such as case studies, study tasks, definitions of key terms and suggestions for further reading. With contributions from leading researchers and health practitioners, this is an invaluable foundation text for any clinical exercise science course, and useful reading for any student or practitioner working in exercise science, exercise rehabilitation, health science or physical therapy. |
| clinical research management ms: Peterson's Graduate Programs in Business, Education, Health, Information Studies, Law & Social Work 2012 Peterson's, 2012-05-15 Peterson's Graduate Programs in Business, Education, Health, Information Studies, Law & Social Work 2012 contains a wealth of info on accredited institutions offering graduate degrees in these fields. Up-to-date info, collected through Peterson's Annual Survey of Graduate and Professional Institutions, provides valuable data on degree offerings, professional accreditation, jointly offered degrees, part-time & evening/weekend programs, postbaccalaureate distance degrees, faculty, students, requirements, expenses, financial support, faculty research, and unit head and application contact information. There are helpful links to in-depth descriptions about a specific graduate program or department, faculty members and their research, and more. Also find valuable articles on financial assistance, the graduate admissions process, advice for international and minority students, and facts about accreditation, with a current list of accrediting agencies. |
| clinical research management ms: Early Drug Development, 2 Volume Set Fabrizio Giordanetto, 2018-12-10 This one-stop reference systematically covers key aspects in early drug development that are directly relevant to the discovery phase and are required for first-in-human studies. Its broad scope brings together critical knowledge from many disciplines, ranging from process technology to pharmacology to intellectual property issues. After introducing the overall early development workflow, the critical steps of early drug development are described in a sequential and enabling order: the availability of the drug substance and that of the drug product, the prediction of pharmacokinetics and -dynamics, as well as that of drug safety. The final section focuses on intellectual property aspects during early clinical development. The emphasis throughout is on recent case studies to exemplify salient points, resulting in an abundance of practice-oriented information that is usually not available from other sources. Aimed at medicinal chemists in industry as well as academia, this invaluable reference enables readers to understand and navigate the challenges in developing clinical candidate molecules that can be successfully used in phase one clinical trials. |
| clinical research management ms: Textbook of Clinical Trials David Machin, Simon Day, Sylvan Green, 2007-01-11 Now published in its Second Edition, the Textbook of Clinical Trials offers detailed coverage of trial methodology in diverse areas of medicine in a single comprehensive volume. Praise for the First Edition: ... very useful as an introduction to clinical research, or for those planning specific studies within therapeutic or disease areas. BRITISH JOURNAL OF SURGERY, Vol. 92, No. 2, February 2005 The book’s main concept is to describe the impact of clinical trials on the practice of medicine. It separates the information by therapeutic area because the impact of clinical trials, the problems encountered, and the numbers of trials in existence vary tremendously from specialty to specialty. The sections provide a background to the disease area and general clinical trial methodology before concentrating on particular problems experienced in that area. Specific examples are used throughout to address these issues. The Textbook of Clinical Trials, Second Edition: Highlights the various ways clinical trials have influenced the practice of medicine in many therapeutic areas Describes the challenges posed by those conducting clinical trials over a range of medical specialities and allied fields Additional therapeutic areas are included in this Second Edition to fill gaps in the First Edition as the number and complexity of trials increases in this rapidly developing area Newly covered or updated in the Second Edition: general surgery, plastic surgery, aesthetic surgery, palliative care, primary care, anaesthesia and pain, transfusion, wound healing, maternal and perinatal health, early termination, organ transplants, ophthalmology, epilepsy, infectious disease, neuro-oncology, adrenal, thyroid and urological cancers, as well as a chapter on the Cochrane network An invaluable resource for pharmaceutical companies, the Textbook of Clinical Trials, Second Edition appeals to those working in contract research organizations, medical departments and in the area of public health and health science alike. |
| clinical research management ms: Strategies for Ensuring Diversity, Inclusion, and Meaningful Participation in Clinical Trials National Academies of Sciences, Engineering, and Medicine, Health and Medicine Division, Board on Population Health and Public Health Practice, Roundtable on the Promotion of Health Equity and the Elimination of Health Disparities, 2016-09-24 Even as the U.S. population becomes steadily more diverse, minorities and women remain underrepresented in clinical trials to develop new drugs and medical devices. Although progress in increasing minority participation in clinical trials has occurred, participation rates do not fully represent the overall population of minorities in the United States. This underrepresentation threatens the health of both these populations and the general population, since greater minority representation could reveal factors that affect health in all populations. Federal legislation has sought to increase the representation of minorities and women in clinical trials, but legislation by itself has not been sufficient to overcome the many barriers to greater participation. Only much broader changes will bring about the meaningful participation of all population groups in the clinical research needed to improve health. To examine the barriers to participation in clinical trials and ways of overcoming those barriers, the National Academies of Sciences, Engineering, and Medicine held a workshop in April 2015. This publication summarizes the presentations and discussions from the workshop. |
| clinical research management ms: A Practical Guide to Managing Clinical Trials JoAnn Pfeiffer, Cris Wells, 2017-05-18 A Practical Guide to Managing Clinical Trials is a basic, comprehensive guide to conducting clinical trials. Designed for individuals working in research site operations, this user-friendly reference guides the reader through each step of the clinical trial process from site selection, to site set-up, subject recruitment, study visits, and to study close-out. Topics include staff roles/responsibilities/training, budget and contract review and management, subject study visits, data and document management, event reporting, research ethics, audits and inspections, consent processes, IRB, FDA regulations, and good clinical practices. Each chapter concludes with a review of key points and knowledge application. Unique to this book is A View from India, a chapter-by-chapter comparison of clinical trial practices in India versus the U.S. Throughout the book and in Chapter 10, readers will glimpse some of the challenges and opportunities in the emerging and growing market of Indian clinical trials. |
| clinical research management ms: A Clinical Trials Manual From The Duke Clinical Research Institute Margaret Liu, Kate Davis, 2011-08-24 The publication of the second edition of this manual comes at an important juncture in the history of clinical research. As advances in information technology make it possible to link individuals and groups in diverse locations in jointly seeking the answers to pressing global health problems, it is critically important to remain vigilant about moral and ethical safeguards for every patient enrolled in a trial. Those who study this manual will be well aware of how to ensure patient safety along with fiscal responsibility, trial efficiency, and research integrity. —Robert Harrington, Professor of Medicine, Director, Duke Clinical Research Institute, Durham, North Carolina, USA The Duke Clinical Research Institute (DCRI) is one of the world's leading academic clinical research organizations; its mission is to develop and share knowledge that improves the care of patients around the world through innovative clinical research. This concise handbook provides a practical nuts and bolts approach to the process of conducting clinical trials, identifying methods and techniques that can be replicated at other institutions and medical practices. Designed for investigators, research coordinators, CRO personnel, students, and others who have a desire to learn about clinical trials, this manual begins with an overview of the historical framework of clinical research, and leads the reader through a discussion of safety concerns and resulting regulations. Topics include Good Clinical Practice, informed consent, management of subject safety and data, as well as monitoring and reporting adverse events. Updated to reflect recent regulatory and clinical developments, the manual reviews the conduct of clinical trials research in an increasingly global context. This new edition has been further expanded to include: In-depth information on conducting clinical trials of medical devices and biologics The role and responsibilities of Institutional Review Boards, and Recent developments regarding subject privacy concerns and regulations. Ethical documents such as the Belmont Report and the Declaration of Helsinki are reviewed in relation to all aspects of clinical research, with a discussion of how researchers should apply the principles outlined in these important documents. This graphically appealing and eminently readable manual also provides sample forms and worksheets to facilitate data management and regulatory record retention; these can be modified and adapted for use at investigative sites. |
| clinical research management ms: Peterson's Graduate Programs in the Biological Sciences 2012 Peterson's, 2012-03-30 Peterson's Graduate Programs in the Biological Sciences 2012 contains a wealth of information on accredited institutions offering graduate degree programs in these fields. Up-to-date data, collected through Peterson's Annual Survey of Graduate and Professional Institutions, provides valuable information on degree offerings, professional accreditation, jointly offered degrees, part-time and evening/weekend programs, postbaccalaureate distance degrees, faculty, students, requirements, expenses, financial support, faculty research, and unit head and application contact information. There are helpful links to in-depth descriptions about a specific graduate program or department, faculty members and their research, and more. There are also valuable articles on financial assistance, the graduate admissions process, advice for international and minority students, and facts about accreditation, with a current list of accrediting agencies. |
| clinical research management ms: Understanding Clinical Research Renato D. Lopes, Robert A. Harrington, 2013-05-22 A complete guide to understanding and applying clinical research results Ideal for both researchers and healthcare providers Understanding Clinical Research addresses both the operational challenges of clinical trials and the needs of clinicians to comprehend the nuances of research methods to accurately analyze study results. This timely resource covers all aspects of clinical trials--from study design and statistics to regulatory oversight--and it delivers a detailed yet streamlined overview of must-know research topics. The text features an accessible three-part organization that traces the evolution of clinical research and explains the bedrock principles and unique challenges of clinical experimentation and observational research. Reinforcing this content are real-life case examples--drawn from the authors' broad experience--that put chapter concepts into action and contribute to a working knowledge of integral research techniques. FEATURES: The most definitive guide to promoting excellence in clinical research, designed to empower healthcare providers to assess a study's strengths and weaknesses with confidence and apply this knowledge to optimize patient outcomes In-depth coverage of fundamental research methods and protocols from preeminent authorities provides readers with an instructive primer and a springboard for ongoing clinical research education Clear, comprehensive three-part organization: Section One: Evolution of Clinical Research offers a succinct history of clinical trials, drug regulations, and the role of the FDA while covering the impact of information technology and academic research organizations Section Two: Principles of Clinical Experimentation takes you through the typical phases of clinical trials in the development of medical products, from initial human subject research to postapproval surveillance studies Section Three: Observational Research highlights the underlying principles, pitfalls, and methods for case-control studies, cohort studies, registries, and subgroup analyses within randomized trials |
| clinical research management ms: Clinical Research Informatics Rachel L. Richesson, James E. Andrews, 2019-02-07 This extensively revised new edition comprehensively reviews the rise of clinical research informatics (CRI). It enables the reader to develop a thorough understanding of how CRI has developed and the evolving challenges facing the biomedical informatician in the modern clinical research environment. Emphasis is placed on the changing role of the consumer, and the need to merge clinical care delivery and research as part of a changing paradigm in global healthcare delivery. Clinical Research Informatics presents a detailed review of using informatics in the continually evolving clinical research environment. It represents a valuable textbook reference for all students and practising healthcare informaticians looking to learn and expand their understanding of this fast-moving and increasingly important discipline. |
| clinical research management ms: NIH Guide for Grants and Contracts , 1991 |
| clinical research management ms: Handbook of Research Methods in Clinical Psychology Michael C. Roberts, Stephen S. Ilardi, 2008-04-15 The Handbook of Research Methods in Clinical Psychology presents a comprehensive and contemporary treatment of research methodologies used in clinical psychology. Topics discussed include experimental and quasi-experimental designs, statistical analysis, validity, ethics, cultural diversity, and the scientific process of publishing. Written by leading researchers, the chapters focus on specific applications of research into psychopathology, assessment and diagnosis, therapy, and interventions for both child and adult populations. Special attention is also given to research into professional issues, prevention, and promotion. Research vignettes describe exemplary projects illustrating the essential elements of the research topics. In addition, the editors outline a research agenda for clinical psychologists that demonstrates the exciting future for the field. This handbook coherently illustrates the range of research methodologies used in clinical psychology and is a vital resource for both students and scholars who wish to expand their knowledge. Covers basic methodologies as well as specific applications of research designs. Includes research vignettes that describe exemplary studies and illustrate the essential elements of the research topics. Contains chapters written by active researchers in the field. Outlines a research agenda for clinical psychologists that demonstrates the exciting future for the field. Now available in full text online via xreferplus, the award-winning reference library on the web from xrefer. For more information, visit www.xreferplus.com |
| clinical research management ms: The Role of Purchasers and Payers in the Clinical Research Enterprise Institute of Medicine, Board on Health Sciences Policy, Clinical Research Roundtable, 2002-06-14 In a workshop organized by the Clinical Research roundtable, representatives from purchaser organizations (employers), payer organizations (health plans and insurance companies), and other stakeholder organizations (voluntary health associations, clinical researchers, research organizations, and the technology community) came together to explore: What do purchasers and payers need from the Clinical Research Enterprise? How have current efforts in clinical research met their needs? What are purchasers, payers, and other stakeholders willing to contribute to the enterprise? This book documents these discussions and summarizes what employers and insurers need from and are willing to contribute to clinical research from both a business and a national health care perspective. |
| clinical research management ms: The Sourcebook for Clinical Research Natasha Martien, Jeff Nelligan, 2018-08-01 A single trial is complex, with numerous regulations, administrative processes, medical procedures, deadlines and specific protocol instructions to follow. And yet, there has existed no single-volume, comprehensive clinical research reference manual for investigators, medical institutions, and national and international research personnel to keep on the shelf as a ready reference to navigate through trial complexities and ensure compliance with U.S. Federal Regulations and ICH GCP until The Sourcebook for Clinical Research. An actionable, step-by-step guide through beginning to advanced topics in clinical research with forms, templates and checklists to download from a companion website, so that study teams will be compliant and will find all the necessary tools within this book. Additionally, the authors developed Display Posters for Adverse Events Plus Reporting and Medicare Coverage Analysis that can be purchased separately here: https://www.elsevier.com/books-and-journals/book-companion/9780128162422/order-display-posters. Moreover, The Sourcebook for Clinical Research contains clear information and guidance on the newest changes in the industry to keep seasoned investigators and staff current and compliant, in addition to providing detailed information regarding the most complex topics. This book serves as a quick, actionable, off-the-shelf resource to keep by your side at the medical clinic. - Makes vital trial conduct information easy to understand and instructs on how to practically apply current Federal regulations and Good Clinical Practice (ICH GCP) - Offers extensive guidance that is crucial for guaranteeing compliance to clinical research regulations during each step of the clinical research process - Provides up-to-date and extensive coverage of beginning to advanced topics, and, step-by-step actions to take during exceptional circumstances, including compassionate use, emergency use, human subjects protections for vulnerable populations, and federal audits - Furnishes a detailed clinical research Glossary, and a comprehensive Appendix containing ready-to-use forms, templates, and checklists for clinical trial personnel to download and begin using immediately. - Written for the fast-paced clinic environment with action steps and forms in the book to respond to a research subject's needs urgently and compliantly |
| clinical research management ms: NIH Guide for Grants and Contracts National Institutes of Health (U.S.), 1990 |
| clinical research management ms: Handbook of Cell and Gene Therapy Hazel Aranha, Humberto Vega-Mercado, 2023-03-17 This handbook provides an in-depth review of information across the developmental spectrum of gene and cell therapy products. From introductory information to state-of-the-art technologies and concepts, the book provides insights into upstream processes such as vector design and construction, purification, formulation and fill/finish, as well as delivery options. Planning steps for compliance with current good manufacturing practice (cGMP) to readiness for chemistry, manufacturing and controls (CMC) are also discussed. This book wraps up with examples of successes and pitfalls addressed by experts who have navigated the multiple challenges that are part of any innovative endeavor. Features Provides the most up-to-date information on the development of gene therapy, from the technology involved to gene correction and genome editing Discusses siRNA, mRNA, and plasmid manufacturing Describes the importance of supplier-sponsor synergies on the path to commercialization Written for a diverse audience with a large number of individuals in the core technologies and supportive practices It is intended as a one-stop resource for the availability of state-of-the-art information related to cell and gene therapy products for researchers, scientists, management and other academic and research institutions. |
| clinical research management ms: Multiple Sclerosis Institute of Medicine, Board on Neuroscience and Behavioral Health, Committee on Multiple Sclerosis: Current Status and Strategies for the Future, 2001-08-10 Multiple sclerosis is a chronic and often disabling disease of the nervous system, affecting about 1 million people worldwide. Even though it has been known for over a hundred years, no cause or cure has yet been discovered-but now there is hope. New therapies have been shown to slow the disease progress in some patients, and the pace of discoveries about the cellular machinery of the brain and spinal cord has accelerated. This book presents a comprehensive overview of multiple sclerosis today, as researchers seek to understand its processes, develop therapies that will slow or halt the disease and perhaps repair damage, offer relief for specific symptoms, and improve the abilities of MS patients to function in their daily lives. The panel reviews existing knowledge and identifies key research questions, focusing on: Research strategies that have the greatest potential to understand the biological mechanisms of recovery and to translate findings into specific strategies for therapy. How people adapt to MS and the research needed to improve the lives of people with MS. Management of disease symptoms (cognitive impairment, depression, spasticity, vision problems, and others). The committee also discusses ways to build and financially support the MS research enterprise, including a look at challenges inherent in designing clinical trials. This book will be important to MS researchers, research funders, health care advocates for MS research and treatment, and interested patients and their families. |
| clinical research management ms: A Manager's Guide to the Design and Conduct of Clinical Trials Phillip I. Good, 2006-04-28 This newly updated edition of the benchmark guide tocomputer-assisted clinical trials provides a comprehensive primerfor prospective managers. It covers every critical issue of thedesign and conduct of clinical trials, including study design,organization, regulatory agency liaison, data collection andanalysis, as well as recruitment, software, monitoring, andreporting. Keeping the same user-friendly format as the original, this SecondEdition features new examples and the latest developments inregulatory guidelines, such as e-submission procedures andcomputerized direct data acquisition. The new edition also reflectsthe increasing globalization of clinical trial activities, andincludes new information about international standards andprocedures, including the Common Technical Document and CDISCstandards. This step-by-step guide is supported by handy checklists andextracts from submitted protocols. Experienced author andconsultant Phillip Good incorporateshumorous yet instructiveanecdotes to illustrate common pitfalls. Based on the provenindustrial formula of planning, implementing, and finallyperforming essential checks, the book's three sections-Plan,Do, and Check-includethe following material: * Should the trials be conducted? * Put it in the computer and keep it there * Staffing for success * Designing trials and determining sample size * Budgeting * Recruiting and retaining patients and physicians * Data management * Monitoring the trials * Data analysis * After action review * Exception handling Executive and managerial professionals involved in the design andanalysis of clinical experiments, along with clinical researchassociates, biostatisticians, and students in public health willfind A Manager's Guide an indispensable resource. Praise for the First Edition: . . . readable, informative and at times witty . . . never stopsbeing concise and well written . . . a book worth a read . .. -Statistics in Medicine The book is very prescriptive and full of lists and tables withwhich to guide managers in making effective decisions in usingcomputer-assisted clinical trials in pharmaceutical studies.-Technometrics This book is must-have reading for anyone in the business . .. -Clinical Chemistry |
| clinical research management ms: Principles and Practice of Clinical Research John I. Gallin, Frederick P Ognibene, 2011-04-28 The second edition of this innovative work again provides a unique perspective on the clinical discovery process by providing input from experts within the NIH on the principles and practice of clinical research. Molecular medicine, genomics, and proteomics have opened vast opportunities for translation of basic science observations to the bedside through clinical research. As an introductory reference it gives clinical investigators in all fields an awareness of the tools required to ensure research protocols are well designed and comply with the rigorous regulatory requirements necessary to maximize the safety of research subjects. Complete with sections on the history of clinical research and ethics, copious figures and charts, and sample documents it serves as an excellent companion text for any course on clinical research and as a must-have reference for seasoned researchers.*Incorporates new chapters on Managing Conflicts of Interest in Human Subjects Research, Clinical Research from the Patient's Perspective, The Clinical Researcher and the Media, Data Management in Clinical Research, Evaluation of a Protocol Budget, Clinical Research from the Industry Perspective, and Genetics in Clinical Research *Addresses the vast opportunities for translation of basic science observations to the bedside through clinical research*Delves into data management and addresses how to collect data and use it for discovery*Contains valuable, up-to-date information on how to obtain funding from the federal government |
| clinical research management ms: Graduate Programs in Engineering & Applied Sciences 2011 (Grad 5) Peterson's, 2011-05-01 Peterson's Graduate Programs in Engineering & Applied Sciences contains a wealth of information on colleges and universities that offer graduate degrees in the fields of Aerospace/Aeronautical Engineering; Agricultural Engineering & Bioengineering; Architectural Engineering, Biomedical Engineering & Biotechnology; Chemical Engineering; Civil & Environmental Engineering; Computer Science & Information Technology; Electrical & Computer Engineering; Energy & Power engineering; Engineering Design; Engineering Physics; Geological, Mineral/Mining, and Petroleum Engineering; Industrial Engineering; Management of Engineering & Technology; Materials Sciences & Engineering; Mechanical Engineering & Mechanics; Ocean Engineering; Paper & Textile Engineering; and Telecommunications. Up-to-date data, collected through Peterson's Annual Survey of Graduate and Professional Institutions, provides valuable information on degree offerings, professional accreditation, jointly offered degrees, part-time and evening/weekend programs, postbaccalaureate distance degrees, faculty, students, degree requirements, entrance requirements, expenses, financial support, faculty research, and unit head and application contact information. As an added bonus, readers will find a helpful See Close-Up link to in-depth program descriptions written by some of these institutions. These Close-Ups offer detailed information about the specific program or department, faculty members and their research, and links to the program Web site. In addition, there are valuable articles on financial assistance and support at the graduate level and the graduate admissions process, with special advice for international and minority students. Another article discusses important facts about accreditation and provides a current list of accrediting agencies. |
| clinical research management ms: Departments of Labor, Health and Human Services, Education, and Related Agencies Appropriations for 1998 United States. Congress. House. Committee on Appropriations. Subcommittee on the Departments of Labor, Health and Human Services, Education, and Related Agencies, 1997 |
| clinical research management ms: University of Michigan Official Publication University of Michigan, 1992 Each number is the catalogue of a specific school or college of the University. |
| clinical research management ms: Designing Clinical Research Stephen B. Hulley, Steven R. Cummings, Warren S. Browner, Deborah G. Grady, Thomas B. Newman, 2011-11-30 Designing Clinical Research sets the standard for providing a practical guide to planning, tabulating, formulating, and implementing clinical research, with an easy-to-read, uncomplicated presentation. This edition incorporates current research methodology—including molecular and genetic clinical research—and offers an updated syllabus for conducting a clinical research workshop. Emphasis is on common sense as the main ingredient of good science. The book explains how to choose well-focused research questions and details the steps through all the elements of study design, data collection, quality assurance, and basic grant-writing. All chapters have been thoroughly revised, updated, and made more user-friendly. |
| clinical research management ms: Peterson's Graduate and Professional Programs Peterson's Guides Staff, Peterson's Guides, 2006-12-17 A basic listing of all accredited graduate programs at universitites in the U.S and Canada. |
| clinical research management ms: Peterson's Graduate Programs in Health-Related Professions 2011 Peterson's, 2011-06-01 Peterson's Graduate Programs in Business, Education, Health, Information Studies, Law & Social Work contains a wealth of information on colleges and universities that offer graduate work in these fields. Institutions listed include those in the United States, Canada, and abroad that are accredited by U.S. accrediting agencies. Up-to-date data, collected through Peterson's Annual Survey of Graduate and Professional Institutions, provides valuable information on degree offerings, professional accreditation, jointly offered degrees, part-time and evening/weekend programs, postbaccalaureate distance degrees, faculty, students, degree requirements, entrance requirements, expenses, financial support, faculty research, and unit head and application contact information. Readers will find helpful links to in-depth descriptions that offer additional detailed information about a specific program or department, faculty members and their research, and much more. In addition, there are valuable articles on financial assistance, the graduate admissions process, advice for international and minority students, and facts about accreditation, with a current list of accrediting agencies. |
| clinical research management ms: Virtual Clinical Trials National Academies of Sciences, Engineering, and Medicine, Health and Medicine Division, Board on Health Sciences Policy, Forum on Drug Discovery, Development, and Translation, 2019-11-16 Successful drug development relies on accurate and efficient clinical trials to deliver the best and most effective pharmaceuticals and clinical care to patients. However, the current model for clinical trials is outdated, inefficient and costly. Clinical trials are limited by small sample sizes that do not reflect variations among patients in the real world, financial burdens on participants, and slow processes, and these factors contribute to the disconnect between clinical research and clinical practice. On November 28-29, the National Academies of Sciences, Engineering, and Medicine convened a workshop to investigate the current clinical trials system and explore the potential benefits and challenges of implementing virtual clinical trials as an enhanced alternative for the future. This publication summarizes the presentations and discussions from the workshop. |
| clinical research management ms: School of Nursing University of California, San Francisco. School of Nursing, 2000 |
| clinical research management ms: Practical Guide to Clinical Data Management Susanne Prokscha, 2011-10-26 The management of clinical data, from its collection during a trial to its extraction for analysis, has become a critical element in the steps to prepare a regulatory submission and to obtain approval to market a treatment. Groundbreaking on its initial publication nearly fourteen years ago, and evolving with the field in each iteration since then, |
| clinical research management ms: Peterson's Graduate Programs in Computer Science & Information Technology, Electrical & Computer Engineering, and Energy & Power Engineering 2011 Peterson's, 2011-05-01 Peterson's Graduate Programs in Computer Science & Information Technology, Electrical & Computer Engineering, and Energy & Power Engineering contains a wealth of information on colleges and universities that offer graduate work these exciting fields. The profiled institutions include those in the United States, Canada and abroad that are accredited by U.S. accrediting bodies. Up-to-date data, collected through Peterson's Annual Survey of Graduate and Professional Institutions, provides valuable information on degree offerings, professional accreditation, jointly offered degrees, part-time and evening/weekend programs, postbaccalaureate distance degrees, faculty, students, degree requirements, entrance requirements, expenses, financial support, faculty research, and unit head and application contact information. Readers will find helpful links to in-depth descriptions that offer additional detailed information about a specific program or department, faculty members and their research, and much more. In addition, there are valuable articles on financial assistance, the graduate admissions process, advice for international and minority students, and facts about accreditation, with a current list of accrediting agencies. |
| clinical research management ms: Envisioning a Transformed Clinical Trials Enterprise in the United States Institute of Medicine, Board on Health Sciences Policy, Forum on Drug Discovery, Development, and Translation, 2012-10-13 There is growing recognition that the United States' clinical trials enterprise (CTE) faces great challenges. There is a gap between what is desired - where medical care is provided solely based on high quality evidence - and the reality - where there is limited capacity to generate timely and practical evidence for drug development and to support medical treatment decisions. With the need for transforming the CTE in the U.S. becoming more pressing, the IOM Forum on Drug Discovery, Development, and Translation held a two-day workshop in November 2011, bringing together leaders in research and health care. The workshop focused on how to transform the CTE and discussed a vision to make the enterprise more efficient, effective, and fully integrated into the health care system. Key issue areas addressed at the workshop included: the development of a robust clinical trials workforce, the alignment of cultural and financial incentives for clinical trials, and the creation of a sustainable infrastructure to support a transformed CTE. This document summarizes the workshop. |
| clinical research management ms: Sustainable Health and Long-Term Care Solutions for an Aging Population Fong, Ben, Ng, Artie, Yuen, Peter, 2017-06-30 Lasting healthcare for the entire population, specifically the elderly, has become a main priority in society. It is imperative to find ways to boost the longevity of healthcare services for all users. Sustainable Health and Long-Term Care Solutions for an Aging Population is a pivotal reference source featuring the latest scholarly research on issues pertinent to health cost and finding effective ways of financing healthcare for the elderly. Including coverage on a number of topics such as provider accreditation, corporate social responsibility, and data management, this book is ideally designed for policy makers, academicians, researchers, and advanced-level students seeking current research on the innovative planning and development of healthcare. |
ClinicalTrials.gov
Study record managers: refer to the Data Element Definitions if submitting registration or results information.
CLINICAL Definition & Meaning - Merriam-Webster
The meaning of CLINICAL is of, relating to, or conducted in or as if in a clinic. How to use clinical in a sentence.
CLINICAL | English meaning - Cambridge Dictionary
CLINICAL definition: 1. used to refer to medical work or teaching that relates to the examination and treatment of ill…. Learn more.
CLINICAL definition and meaning | Collins English Dictionary
Clinical means involving or relating to the direct medical treatment or testing of patients.
Clinical Definition & Meaning | Britannica Dictionary
CLINICAL meaning: 1 : relating to or based on work done with real patients of or relating to the medical treatment that is given to patients in hospitals, clinics, etc.; 2 : requiring treatment as a …
CLINICAL | meaning - Cambridge Learner's Dictionary
CLINICAL definition: 1. relating to medical treatment and tests: 2. only considering facts and not influenced by…. Learn more.
Clinical - definition of clinical by The Free Dictionary
1. pertaining to a clinic. 2. concerned with or based on actual observation and treatment of disease in patients rather than experimentation or theory. 3. dispassionately analytic; …
Clinical - Definition, Meaning & Synonyms | Vocabulary.com
Something that's clinical is based on or connected to the study of patients. Clinical medications have actually been used by real people, not just studied theoretically.
Clinical Definition & Meaning - YourDictionary
Clinical definition: Of, relating to, or connected with a clinic.
Equity Medical | Clinical Research In New York And Kentucky
We pioneer dermatological advancements, collaborating on innovative treatments through research and clinical trials in urban New York City and rural Southern Kentucky.
ClinicalTrials.gov
Study record managers: refer to the Data Element Definitions if submitting registration or results information.
CLINICAL Definition & Meaning - Merriam-Webster
The meaning of CLINICAL is of, relating to, or conducted in or as if in a clinic. How to use clinical in a sentence.
CLINICAL | English meaning - Cambridge Dictionary
CLINICAL definition: 1. used to refer to medical work or teaching that relates to the examination and treatment of ill…. Learn more.
CLINICAL definition and meaning | Collins English Dictionary
Clinical means involving or relating to the direct medical treatment or testing of patients.
Clinical Definition & Meaning | Britannica Dictionary
CLINICAL meaning: 1 : relating to or based on work done with real patients of or relating to the medical treatment that is given to patients in hospitals, clinics, etc.; 2 : requiring treatment as a …
CLINICAL | meaning - Cambridge Learner's Dictionary
CLINICAL definition: 1. relating to medical treatment and tests: 2. only considering facts and not influenced by…. Learn more.
Clinical - definition of clinical by The Free Dictionary
1. pertaining to a clinic. 2. concerned with or based on actual observation and treatment of disease in patients rather than experimentation or theory. 3. dispassionately analytic; …
Clinical - Definition, Meaning & Synonyms | Vocabulary.com
Something that's clinical is based on or connected to the study of patients. Clinical medications have actually been used by real people, not just studied theoretically.
Clinical Definition & Meaning - YourDictionary
Clinical definition: Of, relating to, or connected with a clinic.
Equity Medical | Clinical Research In New York And Kentucky
We pioneer dermatological advancements, collaborating on innovative treatments through research and clinical trials in urban New York City and rural Southern Kentucky.
